RCT TO ASSESS THE EFFECT OF WITHDRAWAL OF INTRAVENOUS IMMUNE GLOBULIN (IVIG) THERAPY FOR SELECTED CHILDREN WITH HIV INFECTION

G Grisaru-Soen, W Lau, C Arneson, D Louch, SE Read, A Bitnun, D Stephens, SM King
The Hospital for Sick Children and University of Toronto, Toronto, Ontario

Hypothesis: IVIG therapy has been used for children with HIV infection for several indications such as prevention of bacterial infections and treatment of thrombocytopenia and LIP. With the availability of combination antiretroviral therapy, many children with HIV infection have improved clinically and immunologically, so that those children started on monthly IVIG pre-ART, may no longer be benefiting from IVIG.
Methods: In a crossover trial, children £18 years with HIV infection which was well controlled on antiretroviral therapy, were randomized to alternating courses of 3 consecutive months of IVIG (400mg/kg) and 3 consecutive months of placebo (0.1% albumin) for a one-year period. The children reported symptoms daily, using a diary, and were assessed clinically and immunologically monthly. The primary outcome measure was days of fever per month. The secondary outcome measures were the frequency of serious infections, changes in HIV viral load (VL), CD4+ cell counts and immune globulin levels.
Results: Fifteen children were enrolled. By the CDC pediatric HIV classification, 8 were C and 7 were B. There were no outcome measures in which the differences were statistically significant. The mean number of days of fever per month with IVIG vs placebo was 0.55 vs 1.46 days. The difference was 0.9 days (95% CI +2.05 to –0.25). There were no serious infections in either period. For the IVIG vs placebo periods, CD4 counts were 976 vs 888 cells/ml, VL 2.90 vs 2.86 log₁₀copies/ml and immune globulin (IgG) levels were 17.1 vs 16.5 g/L.
Conclusion: In children with HIV infection controlled on ART, withdrawal of monthly IVIG did not lead to a significant deterioration in their clinical or immunologic status.